Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A randomised, single-blind, placebo-controlled trial to investigate safety, tolerability, and pharmacokinetics of single rising doses of BI 3000202 administered as tablet to healthy male subjects, and a randomised, open-label, single-dose, two-way cross-over relative bioavailability comparison of BI 3000202 as tablet with and without food in healthy male subjects

This is an early-stage study for a new medicine called BI 3000202, specifically for healthy adult men. The main goals are to see if the medicine is safe and if people can tolerate it well when taking single doses. Researchers also want to understand how the body processes the medicine, like how much gets into the bloodstream and how long it stays there. They will compare taking the medicine as a tablet with food versus without food to see if that makes a difference. This type of study, often called a 'Phase I' trial, is the very first step in testing a new medicine in people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

14 Jun 2023

Healthy volunteer trial

What is this study about?

This study is about a new medicine called BI 3000202. It's an early stage of research, which means it hasn't been tested in people before this. The main goal is to make sure the medicine is safe and that healthy people can take it without serious problems. This is a crucial step before testing the medicine in people who might actually need it for a health condition.

Researchers will be giving the medicine, or a dummy pill (placebo), to healthy men to see how their bodies react. They'll be watching very closely for any side effects. They also want to understand how the medicine moves through the body — how quickly it gets into the blood, how much of it is there, and how long it stays. This helps them work out the best way to give the medicine in the future.

Additionally, a part of the study will check if taking the medicine with food makes any difference to how the body handles it compared to taking it without food. This information is important for working out instructions for patients in the future. Because this is the first time this medicine is being given to people, all of these initial checks are really important to ensure its safe development.

Key takeaways

This is a very early study of a new medicine, BI 3000202.
It aims to check the medicine's safety and how the body handles it in healthy men.
Researchers will also see if food affects how the medicine works.
Participation involves taking the medicine (or a dummy pill) and close medical checks.
It's a 'Phase I' study, the first time this medicine is given to people.
You can withdraw from the study at any point.

Who may be eligible?

This study is looking for healthy male volunteers. You must be at least 18 years old to take part; there is no upper age limit specified, as long as you are healthy enough for the study.

To be considered healthy, you would generally need to have no ongoing significant medical conditions, and not be taking regular medications (unless approved by the study doctor).

The research team will carry out a thorough health check to make sure it's safe for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you male?
Are you 18 years old or older?
Do you consider yourself generally healthy?
Are you willing to discuss your full medical history with the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new medicine (BI 3000202) or a dummy pill (placebo) in tablet form. The study has different parts. In one part, you would receive a single dose, and they would gradually give slightly higher doses to different groups of volunteers to see how you react. In another part, you would take the medicine once with food and once without food, with a break in between. Researchers will monitor your health very closely, often doing blood tests and checking for any side effects. You may need to stay at a clinic for several days for each dose, and there will be follow-up appointments afterwards. The total time you spend in the study will depend on which part you join, but it will involve multiple visits and tests over a period of time.

Potential risks and benefits

Potential benefits of participating include contributing important information to medical science, which could help develop new medicines for the future. You will also receive careful medical monitoring during the study. Potential risks, though, include experiencing side effects from the new medicine, which could be mild or, less commonly, more serious. There might also be discomfort from blood tests or other procedures. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is a 'healthy volunteer' study?

It means the study involves people who generally have no significant health problems. This helps researchers understand how a new medicine works in a healthy body before testing it in patients with an illness.

What is a placebo?

A placebo is a dummy pill that looks exactly like the actual medicine but contains no active drug. It helps researchers compare the effects of the real medicine against taking nothing.

What does a 'Phase I' study mean?

Phase I is the first stage where a new medicine is tested in humans. The main focus is on safety, finding a safe dose, and seeing how the body handles the medicine.

Why are only men being included?

Sometimes, in very early studies, researchers limit participants to one sex to simplify the initial safety and processing data. Future studies might include women.

What does 'with or without food' mean?

This part of the study looks at whether eating food at the same time as taking the medicine changes how well the body absorbs it. This helps set clear instructions for patients in the future.